248 results
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14ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Coherence Dosimetrist, version 2.2. Intended use: Medical charged-particle radiation therapy system
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code MUJ·November 6, 2009
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Catheter, 6", Part Number 2110-0503 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
FDA Recall
Terminated
·Orthovita, Inc., dBA Stryker Orthobiologics.·Product code OAR·November 10, 2012
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Reamer, 8", Part Number 2110-0525 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
FDA Recall
Terminated
·Orthovita, Inc., dBA Stryker Orthobiologics.·Product code OAR·November 10, 2012
DFINE Vertebral Assemblies: Hydraulic-Master Syringe Assembly, StabiliT Vertebral Augmentation System, Reference/Catalog number 3427 - Product Usage: is intended for percutaneous delivery of StabiliT ER2 Bone Cement in kyphoplasty procedures in the treatment of pathological fractures of the vertebrae. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code OAR·February 13, 2020
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Catheter, 8", Part Number 2110-0526 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
FDA Recall
Terminated
·Orthovita, Inc., dBA Stryker Orthobiologics.·Product code OAR·November 10, 2012
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Diamond Needle, 4", Part Number 2110-0506 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
FDA Recall
Terminated
·Orthovita, Inc., dBA Stryker Orthobiologics.·Product code OAR·November 10, 2012
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Beveled Needle, 6", Part Number 2110-0524 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
FDA Recall
Terminated
·Orthovita, Inc., dBA Stryker Orthobiologics.·Product code OAR·November 10, 2012
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger, 6", Part Number 2110-0501 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
FDA Recall
Terminated
·Orthovita, Inc., dBA Stryker Orthobiologics.·Product code OAR·November 10, 2012
Depuy Spine Side Fire Needles 13G X 6IN, part of the Confidence Spinal Cement System Product Code 283904613. The Confidence Side Fire Needle is used to place bone cement in an intra-vertebral fashion at a desired location. the cement extrudes fro the needle through a port on the side of the needle.
FDA Recall
Terminated
·DePuy Mitek, Inc., a Johnson & Johnson Co.·Product code OAR·May 4, 2012
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger Delivery System, 4", Part Number 2090-0501 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
FDA Recall
Terminated
·Orthovita, Inc., dBA Stryker Orthobiologics.·Product code OAR·November 10, 2012
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger, 8", Part Number 2110-0502 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
FDA Recall
Terminated
·Orthovita, Inc., dBA Stryker Orthobiologics.·Product code OAR·November 10, 2012
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Beveled Needle, 4", Part Number 2110-0505 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
FDA Recall
Terminated
·Orthovita, Inc., dBA Stryker Orthobiologics.·Product code OAR·November 10, 2012
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Reamer, 6", Part Number 2110-0504 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
FDA Recall
Terminated
·Orthovita, Inc., dBA Stryker Orthobiologics.·Product code OAR·November 10, 2012
Vertebroplasty Needle Kit 10g Diamond Tip Intended to be used to inject PMMA cement into vertebral bodies during Vertebroplasty procedure.
FDA Recall
Terminated
·Synthes USA HQ, Inc.·Product code OAR·July 30, 2013
PCD Kit: Long 90, 13g Match-Ground w/ Bevel, Product Number: 0506-485-000, UDI: (01)4546540907035 for spinal orthopedic use.
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code OAR·November 9, 2017
KYPHON(R) Directional Bone Filler Device, Size: 3, REF F04C, Rx Only, STERILE R.
FDA Recall
Terminated
·Medtronic Sofamor Danek USA Inc·Product code OAR·May 17, 2017
11g Verteport Cement Cannula (18/pkg), Product Number: 0306-511-000, UDI: (01)7613252594307 for spinal orthopedic use.
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code OAR·November 9, 2017
Medtronic KYPHON(R) Express(TM) Directional Bone Filler Device, SIZE 2, REF FB, QTY 1 EA, Rx only STERILE R
FDA Recall
Terminated
·Medtronic Sofamor Danek USA Inc·Product code OAR·December 6, 2017
DFINE Vertebral Hydraulic Assemblies: Hydraulic Assembly, StabiliT Vertebral Augmentation System, Reference/Catalog number 1402 - Product Usage: is intended for percutaneous delivery of StabiliT ER2 Bone Cement in kyphoplasty procedures in the treatment of pathological fractures of the vertebrae. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code OAR·February 13, 2020
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger Delivery System, 6", Part Number 2090-0505 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
FDA Recall
Terminated
·Orthovita, Inc., dBA Stryker Orthobiologics.·Product code OAR·November 10, 2012